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Amgen Says FDA Completes Review Of SNDA Seeking Full Approval For LUMAKRAS

RTTNews | 367 days ago

Amgen Says FDA Completes Review Of SNDA Seeking Full Approval For LUMAKRAS

(RTTNews) - Amgen, Inc. (AMGN) announced Tuesday that the U.S. Food and Drug Administration (FDA) has completed its review of the company's supplemental New Drug Application seeking full approval of LUMAKRAS (sotorasib).

The review, which resulted in a Complete Response Letter, was based on the CodeBreaK 200 trial results for the treatment of adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC).

The FDA also issued a new postmarketing requirement (PMR) for an additional confirmatory study to support full approval that will be completed no later than February 2028.

In addition, the FDA concluded that the dose comparison PMR issued at the time of LUMAKRAS accelerated approval, to compare the safety and efficacy of LUMAKRAS 960 mg daily dose versus a lower daily dose, has been fulfilled.

The company said LUMAKRAS at 960 mg once-daily will remain the dose for patients with KRAS G12C-mutated NSCLC under accelerated approval.

Tags: AMGN

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Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

Amgen's Bkemv Approved As First Interchangeable Biosimilar To Soliris

The U.S. Food and Drug Administration has approved Amgen Inc.'s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab), developed by British drug major AstraZeneca's Rare Disease unit Alexion Pharmaceuticals, to treat certain rare diseases. Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria or PNH...

RTTNews | 211 days ago

Amgen To Open Manufacturing Site In Central Ohio; To Offer 400 Full-time Jobs

Amgen To Open Manufacturing Site In Central Ohio; To Offer 400 Full-time Jobs

Amgen, Inc. (AMGN) announced Monday the opening of its manufacturing site in Central Ohio, the newest in its global operations network and the most advanced facility to date.

RTTNews | 305 days ago

Amgen, Horizon Therapeutics Reach Settlement On FTC Lawsuit; Seeks To Close Acquisition In Q4

Amgen, Horizon Therapeutics Reach Settlement On FTC Lawsuit; Seeks To Close Acquisition In Q4

Amgen (AMGN) and Horizon Therapeutics plc (HZNP) announced Friday the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen's $27.8 billion acquisition of Horizon.

RTTNews | 483 days ago

Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959

Amgen Announces Positive Top-line Results From Phase 3 DAHLIA Study Of ABP 959

Amgen, Inc. (AMGN) announced Tuesday positive top-line results from the DAHLIA study, a randomized, double-blind, active-controlled, two-period crossover Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

RTTNews | 857 days ago

TSX Ends Modestly Lower

TSX Ends Modestly Lower

https://money.tmx.com/canadian-markets https://www.rttnews.com/3499633/bay-street-likely-to-open-slightly-higher.aspx?type=cn

RTTNews | 5h 50min ago

Dollar Turns In Mixed Performance Against Major Counterparts

Dollar Turns In Mixed Performance Against Major Counterparts

The U.S. dollar turned in a mixed performance against its major counterparts with traders assessing the Federal Reserve's likely moves with regard to interest rates next year.

RTTNews | 6h 20min ago

U.S. Stocks Close Notably Lower; Nasdaq Sheds 1.5 Percent

U.S. Stocks Close Notably Lower; Nasdaq Sheds 1.5 Percent

U.S. stocks tumbled on Friday and the major averages all closed notably lower with the tech-laden Nasdaq suffering a more pronounced loss as yields on 10-Year Treasury Note rose to near 8-month high.

RTTNews | 6h 59min ago

U.S. Stocks Down Firmly In Negative Territory; Nasdaq Tumbled 1.7 Percent

U.S. Stocks Down Firmly In Negative Territory; Nasdaq Tumbled 1.7 Percent

U.S. stocks are down firmly in negative territory Friday afternoon with rising Treasury yields contributing to the weakness. The major averages are all down in the red with the Nasdaq suffering a more pronounced loss.

RTTNews | 8h 59min ago

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